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Completed

NCT Number: NCT04660474

Different Reperfusion Timing and Ventricular Arrhythmias in STEMI Patients

The aim of this study was to investigate the association between different reperfusion timing and ventricular arrhythmias (VAs) to provide evidence for clinical decision-making for patients with ST-segment elevation myocardial infarction (STEMI). All the participants included in the study were diagnosed with STEMI according to the 4th universal definition of myocardial infarction, with a follow-up of 1, 6, 12 months, respectively. Symptom onset-to-reperfusion timing (SO2RT) and 24h-dynamic electrocardiogram parameters were recorded to compare different SO2RT and VAs during 3 follow-up visits.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

About this study

It is Class I recommendation that STEMI require emergency revascularization with no delay. However, arrhythmias after acute myocardial infarction (AMI), particularly VAs, also occur in the early post-MI phase, leading to increased mortality. Previous studies have shown benefits of late reperfusion to electrical stability. The aim of this study was to investigate the association between different reperfusion timing and VAs to provide evidence for clinical decision-making for STEMI. In this multicenter, prospective, observational study, STEMI participants from July 2019 to December 2020 confirmed according to the 4th universal definition of myocardial infarction were enrolled, with a follow-up of 1, 6, 12 months, respectively. SO2RT was defined as the time interval between symptom onset and reperfusion timing which referred to the timing when coronary angiography showed Thrombolysis In Myocardial Infarction (TIMI) blood flow level 2~3 immediately after percutaneous coronary intervention (PCI). The primary end point was VAs on 24h-dynamic electrocardiogram. Secondary outcomes included a composite of death from coronary heart disease, fetal of non-fetal ischemic stroke, revascularization, or chest pain requiring readmission.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • STEMI patients undergoing coronary angiography and PCI;
  • can complete 3 follow-up visits well.

Exclusion criteria

  • without PCI;
  • undergoing thrombolytic therapy;
  • mental diseases;
  • renal failure;
  • stroke sequelae;
  • tumor and a history of revascularization.

Treatment and study plan

Primary outcomes

  1. VAs

    Time frame: 12 months

    The incidence of ventricular arrhythmias on 24h-dynamic electrocardiogram.

Secondary outcomes

  1. Death from coronary heart disease

    Time frame: 12 months

    The incidence of death from coronary heart disease during follow-ups.

  2. Fetal of non-fetal ischemic stroke

    Time frame: 12 months

    The incidence of fetal of non-fetal ischemic stroke during follow-ups.

  3. Revascularization

    Time frame: 12 months

    The incidence of revascularization during follow-ups.

  4. Chest pain requiring readmission

    Time frame: 12 months

    The incidence of chest pain requiring readmission during follow-ups.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Huai'an First People's Hospital
  • The Affiliated Hospital of Hangzhou Normal University
  • The Affiliated Jiangning Hospital of Nanjing Medical University

Registry information

Official study title

Association of Reperfusion Timing With Short- and Medium-term Ventricular Arrhythmias in Patients With ST-segment Elevation Myocardial Infarction: A Prospective Observational Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2020
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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